Duns Number:315018218
Device Description: MARYLAND ADTEC BIPOLAR Grasping Forceps, jaw inserts, curved, (220 mm), diam. 5 mm, fenest MARYLAND ADTEC BIPOLAR Grasping Forceps, jaw inserts, curved, (220 mm), diam. 5 mm, fenestrated, double action, reusable
Catalog Number
PM443R
Brand Name
AESCULAP
Version/Model Number
PM443R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
1f8688c2-384a-4930-ab4d-69af25cc3ae7
Public Version Date
April 12, 2021
Public Version Number
4
DI Record Publish Date
October 10, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |